Accountable for CMC Lifecycle Management of one or more plasma products
Represents the CMC team on the Global Manufacturing & Supply Product team
Leads a cross-functional CMC team to drive effective product Lifecycle Management
Responsible for CMC strategy to enable effective lifecycle initiatives for supply continuity, risk management, line extensions & discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product/process knowledge, capability & improvement, tech transfer, and process validation
Aligns with Global Manufacturing & Supply (GMS) Product team on CMC Lifecycle Management strategy
Drives the link between CMC strategy on the GMS Product team and CMC execution on the CMC subteam
Ensure harmonization/ standardization between facilities and best practice sharing
Accountable to guarantee proper yield tracking and to provide accurate yield status and forecast
Drive Yield projects identification, scoping, prioritization, tracking, and reporting
Is the overall product/process expert for the product; provides bridges across expertise represented on the CMC team
Accountable for CMC sections of product dossiers
Provide Subject Matter Expertise of major process and methods investigations
Assess and provide feedback to cross-functional technical proposals and recommendations
Manage multiple workstreams and projects
Make sound and timely decisions based on project priorities.
Discern paths forward within ambiguous environments
Skills and Qualifications:
Higher Degree in engineering or life sciences
Experience operating globally in a matrix organization highly preferred
Profound and relevant technical experience, preferably within the plasma business
Experience defining the strategy and roadmap for complex, cross-functional CMC initiatives
Ideally deep and broad understanding of plasma manufacturing, the regulatory environment, life cycle management, trends in innovation, and financial acumen
Self-motivated with good interpersonal and communication skills, capable of analyzing and solving complex problems through innovative thought and experience, as well as, project management tools
Strategic enterprise thinking, finding innovative ways to serve patients to build reputation and trust
Creating an environment that inspires and enables people
Excellent command of the English language is essential, any other language is an asset
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work - life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer. For more insights into Takeda click here.
We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.
Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 4.369,11 gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.